Guidance Maps Out Codevelopment Pathways for Companion Diagnostics, Drugs July 19, 2016 The guidance describes general principles to guide codevelopment. Read More
Terumo Finalizes Acquisition of Sequent Medical July 18, 2016 Terumo initially announced the acquisition back in June. Read More
Pfizer’s Sutent Meets Primary Endpoint in Pivotal Trial July 18, 2016 The candidate met its primary endpoint of prolonging disease-free survival. Read More
Ximedica Purchases Accel Biotech July 15, 2016 Accel will maintain its presence in Silicon Valley. Read More
Two Compounders Hit for Quality Control Issues July 15, 2016 The FDA pummeled one of the compounders with 13 citations. Read More
FDA Places Clinical Hold on Juno Trials Following Three Deaths July 14, 2016 Three patients died from cerebral edema. Read More
Health Canada Greenlights Cynosure’s SculpSure July 13, 2016 The device is designed to treat non-invasive lipolysis of the abdomen and flanks. Read More
Guidance Sets Compliance Limits for Compounding Near Replicas of Approved Drugs July 13, 2016 The document says compounders should not produce near-duplicate drugs. Read More
Alafair Biosciences’ VersaWrap Tendon Protector Wins FDA Clearance July 12, 2016 The product is “ultrathin” and “sutureless.” Read More
Clinical Investigators Cited for Protocol Deviations in 483s July 12, 2016 Three clinical investigators were hit for deviating from their investigational plans. Read More